Red Blood Cell Precursor Formulation to Determine Increased Production

Phase 2

Withdrawn

• Conditions: Anemia
• Interventions: Drug: RBCPF

• Registration Number: NCT01701531
• Lead Sponsor: Targeted Medical Pharma

Brief Summary

The objective of this study is to measure the change in hemoglobin levels after the administration of an amino acid based, RBC precursor formulation.

Detailed Description

Medical foods are a distinct FDA regulatory category different from single molecule chemical pharmaceuticals, and from dietary supplements. The FDA has regulated amino acid preparations as drugs since the 1940s as they can elicit pharmacologic effects similar to conventional single molecule pharmaceuticals. The best known amino acid preparations are used to treat conditions such as maple syrup disease and phenylketonuria (PKU). An official definition and categorization of medical foods was made in 1988 as part of the Orphan Drug Act. Medical foods are regulated similarly to drugs except they do not require pre-approval because all ingredients are found on the FDA's generally recognized as safe (GRAS) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act) list and claims are confined to the nutritional management of a specific disease. Medical food claims must be supported by recognized scientific data as determined by medical evaluation. A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-03
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-04
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. M/F patients 18 to 75 years old, non-pregnant/lactating
2. Male patients with < Hemoglobin of 12.5
3. Female Patients with < Hemoglobin of 11
4. Diagnosis of mild to moderate anemia by study physician

Exclusion Criteria

1. Pregnant or unwilling to use adequate birth control for the duration of the study.
2. Unwilling or unable to sign informed consent.
3. Myocardial infarction within the last 6 months.
4. Patients currently taking an erythropoietin medication and unable to discontinue for the duration of the study.
5. GI bleed in the last 6 months.
6. Inflammatory bowel disease.
7. Chronic liver disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RBCPF	RBCPF	Treatment intervention arm

Primary Outcome Measures

Name	Time	Method
Change in hemoglobin level 2 hours after administration of the first dose.	Baseline, 2 hours and 7 days	Subjects will have blood drawn at baseline and 2 hours after the administration of the treatment intervention. Then again, after 7 days.

Secondary Outcome Measures

Name	Time	Method
CBC w/ differential	Baseline, 2 hours and 7 days
Erythropoietin level	Baseline, 2 hours and 7 days
Reticulocytes	Baseline, 2 hours and 7 days
Iron levels	Baseline, 2 hours and 7 days
Ferritin	Baseline, 2 hours and 7 days
IGG	Baseline, 2 hours and 7 days
B12	Baseline, 2 hours and 7 days

Trial Locations

Locations (1)

Lawrence May, MD, Inc.; 🇺🇸 Tarzana, California, United States